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510(k) K855050

Device
STORZ E9040 & E9046 DIAMOND KNIVES
Applicant
STORZ INSTRUMENT CO.
510(k) number
K855050
Product code
HNN  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-05
Date received
1985-12-17
Regulation
886.4350
Classification name
Knife, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAN REGAN
Address
3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.2011-05-20
K922378OPHTHALMIC KNIFEMicroptics Development Laboratory1992-12-10
K882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical Center1988-08-22
K881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.1988-05-13
K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.1988-04-13
K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, Inc.1987-12-23
K874056OPHTHALMIC DISPOSABLE BLADESMyocure, Inc.1987-12-22
K873385OPHTHALMIC PHACO-BLADEMyocure, Inc.1987-09-21
K871285KNIFE, OPHTHALMICTrueline Instruments, Inc.1987-04-27
K864290RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGEKeeler Instruments, Inc.1986-12-15
K863725CATARACT DIAMOND KNIFEMedical Technology Development Corp.1986-10-31
K863665THE ULTIMATEMyocure, Inc.1986-09-25
K861744SAPPHIRE KNIFE BLADEKeeler Instruments, Inc.1986-06-09
K861748RUBY & SAPPHIRE BLADE HOLDERKeeler Instruments, Inc.1986-06-02
K861491ROPHAE DIAMOND KNIFERophae Lens Co., Inc.1986-05-28

Legacy Summary#

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FDA Review#

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